Group Leader, Manufacturing Quality Assurance

Catalent

Not specified; not specified; competitive medical ...
Fda regulations compliance
Gxp standards adherence
Batch record review and release
The Group Leader provides leadership and day-to-day oversight for QA activities supporting commercial manufacturing operations

Job Summary

  • The Group Leader provides leadership and day-to-day oversight for QA activities supporting commercial manufacturing operations.
  • Candidates must ensure all manufacturing and testing processes comply with FDA regulations, GxPs, and internal SOPs while managing batch releases.
  • Catalent offers competitive medical benefits, 401K, 152 hours of PTO plus 8 paid holidays, and opportunities to work on continuous improvement processes.

Matching Summary

The Group Leader provides leadership and day-to-day oversight for QA activities supporting commercial manufacturing operations.

Salary

Not specified; Not specified; Competitive medical benefits and 401K included

Skills & Requirements

Must-have

  • FDA regulations compliance
  • GxP standards adherence
  • Batch record review and release
  • Investigation and deviation management
  • CAPA root cause analysis

Nice-to-have

  • Team leadership capability
  • Customer discussion resolution
  • Continuous improvement drive
  • Metrics generation and presentation
  • Dynamic fast-paced environment

Key Requirements

  • BS/BA in related field with 2+ years experience
  • Associate degree with 5+ years experience
  • Demonstrated team leadership capability
  • Experience solving routine and non-routine quality issues

Work Rights

Not specified

Tailored Resume

Cover Letter